The Point-of-care (POC) Manufacturing of Medical Devices - Complex Manufacturing Hubs in Healthcare Facilities Working Group met for the first time on 1 December 2023 via videoconference.
Key discussion points included:
- The introduction of the personalised medical devices framework and the implications for the complex manufacturing hubs in healthcare facilities.
- The regulation of point-of-care manufacturing and convening a National Symposium attended by state/territory government health departments and federal regulators.
- The role and purpose of the POC Manufacturing of Medical Devices Steering Committee and maintaining active channels of communication to facilitate the timely sharing of information between the Steering Committee and the Working Group.
- The importance of leveraging the collective experience of Working Group participants and feedback from their members to ensure any potential options/solutions put forward by the Steering Committee are fit-for-purpose, focus on patient safety and do not introduce any unnecessary regulatory burden.
- Regulation of those undertaking POC manufacturing in healthcare facilities and how existing frameworks and arrangements for the registration, education, qualifications, and standards of practice can be leveraged to support this work.
- The feasibility of developing a set of common national standards for additive manufacturing of medical devices at the POC, covering elements such as design, biocompatibility, and sterility for medical device POC manufacturers to comply with and be audited against.
More information
Meeting statements and information on the POC Manufacturing of Medical Devices - Complex Manufacturing Hubs in Healthcare Facilities Working Group, visit Point-of-care Manufacturing of Medical Devices Steering Committee and Working Groups.